On November 12, 2021 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that new study data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Phio Pharmaceuticals, NOV 12, 2021, View Source [SID1234595403]). The data from this study in an in vivo hepatocarcinoma model shows that PH-762 administered locally clears untreated distal tumors, indicating a systemic immune response.

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"We are very excited with this new data on PH-762, our lead product candidate," said Dr. Simon Fricker, Phio’s VP of Research & Development. "These new results, along with a growing body of mechanistic data collected thus far, provide a compelling argument for the clinical potential of PH-762. It furthermore continues to show the potential of our INTASYL platform in various applications, including direct therapeutic use."

The Company has previously presented data showing that local administration of PH-762, our PD-1 targeting INTASYL compound, produces a robust silencing of PD-1 and changes in the tumor microenvironment associated with anti-tumor activity. In this new study, tumors were implanted in mice and treated locally with PH-762. In addition, to determine an abscopal effect or systemic immune response, tumors were also implanted on the opposite side of the original tumor and left untreated. Results showed that PH-762 significantly inhibited growth of treated tumors, but furthermore, the growth of the untreated tumor was also significantly reduced, resulting in 80% of these untreated tumors becoming completely cured. These data indicate that local treatment with PH-762 provides a robust anti-tumor efficacy to both locally treated tumors and to untreated distal tumors, suggesting an abscopal effect, due to a systemic immune response. As such, the results indicate that INTASYL therapeutic use can represent an alternative to systemic antibody checkpoint therapy with potential for improved efficacy and reduced systemic toxicity. This systemic anti-tumor response toward distant tumors and metastases will be investigated in our upcoming Phase 1 clinical trial for locally administered PH-762 in patients with melanoma.

Phio’s presentation detailing the data presented at SITC (Free SITC Whitepaper) titled, "Locally administered immunotherapy self-delivering RNAi PH-762 results in abscopal clearance of untreated distal tumors, suggesting systemic immune response, in a murine hepatocarcinoma model" will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here).

On November 12, 2021 Nimbus Therapeutics, a biotechnology company designing and developing breakthrough medicines through structure-based drug discovery, reported the first patient dosed in the first-in-human Phase 1/2 study of their small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, NDI-101150 (Press release, Nimbus Therapeutics, NOV 12, 2021, View Source [SID1234595402]). HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, making it a high-priority target in immuno-oncology.

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"We are proud to expand our clinical development program with the initiation of this first-in-human trial. The preclinical evidence we’ve seen for our HPK1 inhibitors to date, including in vivo data shared at the 2021 AACR (Free AACR Whitepaper) Annual Meeting, has shown significant tumor growth inhibition, both as a single agent and in combination with anti-PD1, and robust and durable effects on immune memory," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "New approaches to expand the promise of immuno-oncology to solid tumors are greatly needed and we’re eager to explore the potential of NDI-101150 to help address this unmet need."

The Phase 1/2 trial is a multicenter, open-label study that will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. It is planned to enroll approximately 106 subjects.

"HPK1 is an important therapeutic target in immuno-oncology because of its role in multiple adaptive immune system components, including T cell, B cell and dendritic cell-mediated immune responses. We are pleased to have progressed a highly-selective HPK1 inhibitor into the clinic," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "Development of this agent was made possible by Nimbus’ computational drug discovery approach, which continues to provide opportunities to develop new medicines in diseases with high unmet medical need."

On November 12, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for the third quarter of 2021 (Press release, NexImmune, NOV 12, 2021, View Source [SID1234595401]).

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"We had another strong quarter as characterized by our continued progress developing the AIM technology platform," said Scott Carmer, Chief Executive Officer. "Our primary focus remains on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002. We plan to provide clinical updates for the NEXI-001 trial in AML during the first half of 2022 and will update the NEXI-002 trial in relapsed / refractory multiple myeloma at the upcoming ASH (Free ASH Whitepaper) conference. Additionally, we are presenting the antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies at the SITC (Free SITC Whitepaper) Annual Meeting. Finally, we’re very excited with the progress of our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for Type 1 Diabetes. Our team looks forward to providing future updates on these and other important projects as we continue to progress the development of our AIM technology across a range of therapy areas and with multiple modalities."

Select 3Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses across all dose levels with signs of increased clinical activity associated with higher doses
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Investigational New Drug (IND) submission planned for mid-year 2022
Other R&D

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic in Type 1 diabetes
Business Updates

Announced the appointments of Dr. Jack Ragheb as SVP, Translational Medicine, and Matthew Schiller as Head of Business Development
Select 3Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of September 30, 2021 were $93.2M compared to $102.8M for quarter ending June 30, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements through 4Q22.

Research and development expenses were $11.3M in the third quarter of 2021, compared to $4.9M for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.2M, compared to $2.8M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $14.6M for the quarter, or a basic and diluted GAAP loss per share of $0.65. This compared to a net loss of $8.6M, or a basic and diluted GAAP loss per share of $7.52, for the same period the prior year.

On November 12, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported third quarter 2021 financial results and provided business highlights (Press release, Lyell Immunopharma, NOV 12, 2021, View Source [SID1234595400]).

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"We continue to advance our multi-modality pipeline and remain on track to submit four INDs by the end of 2022 and are expanding our organizational capabilities across research, development and manufacturing to support our pipeline." said Liz Homans, Chief Executive Officer of Lyell. "Our team is preparing to initiate multiple clinical trials incorporating our two platforms that enable T cells to overcome exhaustion and maintain durable stemness in the solid tumor microenvironment, and we look forward to elucidating the potential clinical benefits of these technologies."

Third Quarter 2021 Financial Results

GAAP and Non-GAAP Operating Results

Research and Development (R&D) Expenses were $31.4 million for the three months ended September 30, 2021, compared to $24.5 million for the same period in 2020. The increase in R&D expense on a GAAP basis was primarily due to increases in facilities and technology costs and personnel-related expenses, partially offset by a decrease in success payments expenses. Non-GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the third quarter ended September 30, 2021 were $28.7 million, compared to $21.3 million for the same period in 2020.
General and Administrative (G&A) Expenses were $21.2 million for the three months ended September 30, 2021, compared to $13.6 million for the same period in 2020. The increase in G&A expense on a GAAP basis was primarily due to an increase in personnel-related expenses, including stock-based compensation expense. Non-GAAP G&A expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2021 were $10.9 million, compared to $5.8 million for the same period in 2020.
Net loss was $48.9 million for the three months ended September 30, 2021, compared to $35.7 million for the same period in 2020. Non-GAAP net loss, which excludes non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, was $35.7 million for the third quarter ended September 2021, compared to $24.7 million for the same period in 2020.
A discussion of these non-GAAP financial measures, including reconciliations of GAAP to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2021 were $936.4 million, compared to $692.6 million as of December 31, 2020, an increase of $243.8 million. Lyell successfully completed its initial public offering in June 2021 in which it issued 25 million shares of common stock, at a price of $17.00 per share, for net proceeds of $391.8 million, after deducting underwriting discounts and commissions and offering expenses.

On November 12, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it will host a virtual Key Opinion Leader (KOL) event regarding the potential treatment of pancreatic cancer utilizing Lantern Pharma’s drug candidate LP-184, on World Pancreatic Cancer Day, Thursday, November 18th at 12:00 pm EST (Press release, Lantern Pharma, NOV 12, 2021, View Source [SID1234595399]).

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The event will be cohosted by:

Dr. Igor Astsaturov, an established, NCI-funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center
Dr. Ira Sharp, retired internal medicine specialist, as well as a pancreatic cancer survivor and cancer patient advocate
Dr. Kishor G. Bhatia, Chief Scientific Officer of Lantern Pharma
The event will feature discussions on the recent advances of LP-184, a PTGR1-activated small molecule that leverages DNA repair deficiency to selectively eradicate pancreatic cancers, and potential clinical uses of LP-184 in an upcoming Phase I clinical trial.

Lantern Pharma’s Virtual KOL Event details are as follows:

Thursday, November 18, 2021, 12:00 pm EST- 1:00 pm EST
To register for the webinar, please sign up here: View Source
A replay of the webinar will be available on the investor relations section of the Company’s website: ir.lanternpharma.com
Pancreatic cancer is the fourth leading cause of cancer deaths in the United States with a five-year survival rate of 7.9% and a 10-year survival rate of just 1%. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 new cases of pancreatic cancer globally on an annual basis, with over 62,000 of those cases occurring in North America. Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease. LP-184 is designed to target a specific subset of pancreatic cancer patients that are genetically defined, which has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

LP-184 is in pre-clinical development for several targeted indications in cancer, including pancreatic cancer and glioblastoma. LP-184 preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer, and also for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas.